By Rich Haridy June 29, 2022
New data, yet to be peer-reviewed and published in a journal, indicates Novavax’s vaccine induces a strong antibody response against all circulating Omicron variants Depositphotos
Biotech company Novavax has revealed its COVID-19 vaccine can generate effective immune responses against all circulating Omicron variants. The unexpected data was delivered to an advisory panel convened by the US Food and Drug Administration (FDA) to recommend booster vaccine plans for later this year.
The newly revealed data came as a surprise in a meeting ostensibly focused on presentations from Pfizer and Moderna surrounding their mRNA COVID-19 vaccine studies targeting new Omicron-specific formulations. Peter Marks, director of the FDA’s vaccine department, said although Novavax’s vaccine has yet to be authorized for use in the United States it was important to have the company present this data to help the panel understand how it could fit into booster plans for later this year.
Novavax’s COVID-19 vaccine has faced a rocky road to authorization in the United States. It was initially part of Operation Warp Speed in early 2020, the first wave of US government funding pushing development for a COVID-19 vaccine. Development challenges and manufacturing hurdles slowed things down in 2021 but by the end of the year the novel vaccine began to be distributed around the world.
In the US authorization for Novavax’s vaccine has been slow. The company reportedly submitted data to the FDA back in January but manufacturing issues continued to hold back authorization. In early June an FDA advisory panel recommended emergency use authorization for the vaccine and again questions were raised over manufacturing standards, leading to a pause in final approval.
“We take manufacturing very seriously,” Marks recently said. “We don’t benchmark ourselves against other countries when it comes to manufacturing, we consider that we have a very high standard, and it’s why we’re often considered a gold standard for our manufacturing, and particularly in the area of vaccines.”
The new data revealed by Novavax indicates its original vaccine formulation seems to generate broad immune responses, resulting in antibodies that display effective responses to all new Omicron variants, including the most immune-evasive BA.5 subtype. In particular, the data indicates a booster shot of Novavax’s vaccine generates neutralizing antibody responses to Omicron variants comparable to what was seen against the original strain of SARS-CoV-2 at the peak of its initial Phase 3 trial.
The data supplied by Novavax shows a booster shot, delivered eight months beyond the primary series, generates a strong immune response against all Omicron subtypes Novavax
This data has yet to be peer-reviewed and published in a journal Novavax
Novavax believes its vaccine is likely more effective against emerging SARS-CoV-2 variants compared to mRNA vaccines because it uses a different kind of vaccine technology. This vaccine is known as a protein subunit vaccine and its production involves initially cultivating the infamous coronavirus spike proteins in large manufacturing facilities. The proteins are the assembled into nanoparticles designed to mimic the structure of the virus. These nanoparticles are paired with adjuvants, molecules that help boost the body’s immune response.
Novavax claims the unique structural features of its vaccine lead to the generation of broad cross-neutralizing antibodies that can better detect emerging SARS-CoV-2 variants. Backing up this hypothesis, Novavax presented data from its newest vaccine formulation designed to more directly target the Omicron BA.1 variant.
Animal studies testing a newer formulation more specifically targeting Omicron BA.1 revealed little difference in antibody responses compared to the original formulation Novavax
The data suggests little difference in antibody responses to Omicron variants when comparing the original vaccine to a newer formulation. Novavax argues this means booster programs using the original formulation could likely be an effective strategy for later this year. However, ongoing trials with the Omicron-specific formulation should deliver results soon and Novavax says it is able to supply this iteration of the vaccine if necessary.
“We are confident that our prototype COVID-19 vaccine generates broad levels of antibodies as a primary series, and that boosting with this prototype vaccine increases the magnitude of the breadth of response,” said Gregory Glenn, Novavax’s head of research and development. “While we believe in the strength of our prototype vaccine data, we are prepared to supply an Omicron-based vaccine this fall in accordance with health authority recommendations.”
To date, Novavax’s COVID-19 vaccine has been authorized and distributed in more than 40 countries around the world, including Europe, Canada and Australia. The company indicates its supply lines are strong enough to begin supplying the US with boosters of its original formulation immediately and Omicron-targeted doses by the end of the year.
Source: Novavax
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